Seal anchor with non-parallel lumens

ABSTRACT

A seal anchor member defines a housing defining a longitudinal axis, the housing having leading and trailing ends, and including a plurality of lumens extending between the leading and trailing ends, each lumen being adapted for substantially sealed reception of an object therein and defining a longitudinal axis, wherein at least two of the lumens define longitudinal axes that are non-parallel to facilitate angled, at-rest placement of multiple instruments within the seal anchor member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/248,520 filed Apr. 9, 2014, which is a continuation of U.S. patentapplication Ser. No. 13/891,717 filed May 10, 2013, which is acontinuation of U.S. patent application Ser. No. 12/887,847 filed Sep.22, 2010, which claims benefit of U.S. Provisional Application No.61/247,654 filed Oct. 1, 2009, and the disclosures of each of theabove-identified applications are hereby incorporated by reference intheir entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to a seal for use in a surgicalprocedure. More particularly, the present disclosure relates to a sealanchor member adapted for insertion into an incision in tissue andincluding a plurality of non-parallel lumens adapted for the sealedreception of one or more surgical objects such that a substantiallyfluid-tight seal is formed with both the tissue and the surgical objector objects.

2. Background of the Related Art

Today, many surgical procedures are performed through small incisions inthe skin, as compared to the larger incisions typically required intraditional procedures, in an effort to reduce both trauma to thepatient and recovery time. Generally, such procedures are referred to as“endoscopic”, unless performed on the patient's abdomen, in which casethe procedure is referred to as “laparoscopic”. Throughout the presentdisclosure, the term “minimally invasive” should be understood toencompass both endoscopic and laparoscopic procedures.

During a typical minimally invasive procedure, surgical objects, such assurgical access devices (e.g., trocar and cannula assemblies) orendoscopes, are inserted into the patient's body through an incision intissue. In general, prior to the introduction of the surgical object orinstrument into the patient's body, insufflation gasses are used toenlarge the area surrounding the target surgical site to create alarger, more accessible work area. Accordingly, the maintenance of asubstantially fluid-tight seal is desirable so as to prevent the escapeof the insufflation gases and the deflation or collapse of the enlargedsurgical site.

To this end, various valves and seals are used during the course ofminimally invasive procedures and are widely known in the art. Variousseals have been developed including lumens for the reception of surgicalinstruments. Depending upon the needs of a particular surgicalprocedure, instruments may need to be angled with respect to one anotherfor extended periods of time. Holding the instruments at angles withrespect to one another and/or overcoming the internal biases of the sealanchor member through which the instruments are inserted may fatigue thesurgeon and/or breach the fluid-tight barrier between the seal anchormember and surrounding tissue.

Accordingly, a continuing need exists for new seal anchor members thatcan be inserted directly into the incision in tissue and that canaccommodate a variety of surgical objects or instruments whilemaintaining the integrity of an insufflated workspace.

SUMMARY

Disclosed herein is a seal anchor member including a housing includingleading and trailing ends, and one or more lumens extendingtherethrough. Each of the lumens is adapted for receiving a surgicalinstrument in a substantially sealed reception. The one or more lumensare angled with respect to a longitudinal axis of the housing. At leasttwo of the lumens define axes that are non-parallel with respect to oneanother. In an embodiment, the housing may include a plurality oflumens, e.g., three lumens, in which one of the lumens is parallel withrespect to the longitudinal axis and the other two lumens arenon-parallel with respect to each other and the longitudinal axis. Asdescribed herein, the lumens, while defining axes that are intersecting,do not cross each other since the lumens are laterally spaced apart,e.g., the axes, not the lumens, are intersecting when the housing isviewed in a side cross-sectional view. This arrangement of the lumensfacilitates the simultaneous, non-parallel placement of multiplesurgical objects or instruments within the seal anchor member. However,in other embodiments, the lumens may be intersecting.

Furthermore, the lumens may define openings at the leading end that areradially spaced apart about the trailing end. Alternatively, the lumensmay define openings at the leading end that are spaced along a diameterof the trailing end. The openings defined by the lumens may be staggeredabout an axis of the trailing end or may be positioned along a diameterbut offset from that diameter. Alternatively, the openings defined bythe lumens may be positioned on a chord or a diameter of the trailingend.

The housing may be formed from a compressible material to facilitateadjusting the angles between instruments inserted within the lumens andwith respect to the longitudinal axis of the housing. In the absence ofa force, e.g, a radial force, upon the instruments inserted within thelumens, the lumens are angled, i.e., non-parallel, with respect to eachother. During use, the angles of the lumens are adjustable by applying aforce.

The leading end may include a groove, cut-out, or recess that ispositioned adjacent to the proximal end of at least one of the lumens.The groove is configured and adapted to facilitate the insertion of theinstrument into the lumen by stabilizing the instrument and leading theinstrument into the lumen. The groove may be generally arcuate. Thegroove may narrow from the proximal end to the distal end of the groove.The groove may extend radially outward from the proximal end of the atleast one lumen.

Furthermore, the housing of the seal anchor may be adapted to transitionbetween a first compressed condition to facilitate at least partialinsertion of the seal anchor member within a tissue tract, and a secondexpanded condition to facilitate securing of the seal anchor memberwithin the tissue tract and in substantial sealed relation with tissuesurfaces defining the tissue tract. In an embodiment, the housing may beformed from a compressible material or from a foam material. In anembodiment, the foam material may be at least partially constituted of amaterial selected from the group consisting of polyisoprene, urethane,and silicone. In another embodiment, the housing may be formed from agel material.

The housing may also define a substantially arcuate configuration. Thehousing may define a substantially hour glass shape. Furthermore, thelumens may define openings at the leading end that are radially spacedapart about the trailing end. Alternatively, the lumens may defineopenings at the leading end that are spaced along a diameter of thetrailing end. The openings defined by the lumens may be staggered aboutan axis of the trailing end or may be positioned along a diameter butoffset from that diameter. Alternatively, the openings defined by thelumens may be positioned on a chord or a diameter of the trailing end.

These and other features of the apparatus disclosed herein will becomemore readily apparent to those skilled in the art from the followingdetailed description of various embodiments of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith references to the drawings, wherein:

FIG. 1 is a front perspective view of a seal anchor in accordance withthe present disclosure shown relative to tissue;

FIG. 2A is a front perspective view of a seal anchor member havinglumens therein that are parallel to one another;

FIG. 2B is a front perspective view of the seal anchor of FIG. 1 shownwith medical instruments inserted therein;

FIG. 3 is another embodiment of a seal anchor in accordance with thepresent disclosure; and

FIG. 4 is a yet another embodiment of a seal anchor in accordance withthe present disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In the drawings and in the description which follows, in which likereferences numerals identify similar or identical elements, the term“proximal” will refer to the end of the apparatus which is closest tothe clinician during use, while the term “distal” will refer to the endwhich is furthest from the clinician, as is traditional and known in theart. A seal anchor for use in a surgical procedure is shown anddescribed in U.S. Pat. Pub. 2009-0093752, the entire contents of whichare hereby incorporated by reference. The seal anchor member may be usedduring a minimally invasive procedure in which the seal anchor isinserted into an incision. Alternatively, the seal anchor may be usedthrough a naturally occurring opening (e.g., anus or vagina) or anyincision in a patient's skin.

The use and function of seal anchor member 100 will be discussed duringthe course of a typical minimally invasive procedure. Initially, theperitoneal cavity (not shown) is insufflated with a suitablebiocompatible gas such as, e.g., CO₂ gas, such that the cavity wall israised and lifted away from the internal organs and tissue housedtherein, providing greater access thereto. The insufflation may beperformed with an insufflation needle or similar device, as isconventional in the art. Either prior or subsequent to insufflation, atissue tract 12 is created in tissue “T”, the dimensions of which may bevaried dependent upon the nature of the procedure.

A seal anchor 100 will now be described with reference to FIGS. 1 and 2.The seal anchor 100 defines a longitudinal axis “A” and has respectivetrailing (or proximal) and leading (or distal) ends 102, 104 and anintermediate portion 106 disposed between the trailing and leading ends102, 104. Seal anchor member 100 includes one or more lumens (or ports)108 a, 108 b, 108 c disposed between the trailing and leading ends 102,104 that define corresponding longitudinal axes “X”, “Y”, “Z”. As seenin FIG. 1, the axes “X”, “Y”, “Z” defined by the lumens 108 a, 108 b,108 c, respectively, are non-parallel with respect to one another. Tofacilitate the simultaneous placement of instruments into each of thelumens 108 a, 108 b, 108 c, the lumens 108 a-c do not cross one another.The lumens 108 a-c are laterally spaced apart such that, although thelumens 108 a-c are angled with respect to one another, the lumens 108a-c do not intersect one another. In other embodiments, however, lumensmay be arranged to cross one another. In contrast to seal anchor 100, aseal anchor 90 having parallel, non-intersecting lumens 98 isillustrated in FIG. 2A.

As seen in FIG. 2B, the lumens 108 a-c are adapted to receiveinstrumentation therein in a substantially sealed manner. The lumens 108a-c are adapted to inhibit the escape of insufflation gasses within abody cavity with or without instrumentation being inserted therein.Accordingly, the lumens 108 a-c have diameters that are adapted tocontract in the absence of a surgical instrument inserted therein andare adapted to expand to accommodate instrumentation in a substantiallysealed manner.

As shown in FIG. 2B, the instrumentation inserted within the lumens 108may include, but are not limited to, a camera 20 that may be insertedwithin one of the lumens 108 and a pair of surgical instruments 21 thatare inserted into two of the other lumens 108. Since the axes “X” and“Z” of the two lumens 108 a, 108 c, through which the pair of surgicalinstruments 21 are inserted, cross one another, the distance between thedistal ends of the surgical instruments 21 is greater than it would beif the axes “X”, “Z” were parallel to one another. Since the lumens 108a, 108 c define non-parallel axes, manipulation of the surgicalinstruments 21 is facilitated since there is a lesser probability of theinstruments 21 interfering with each other's use. Furthermore, since theat-rest state for the lumens 108 a-c is at angles with respect to oneanother, surgeon fatigue is reduced for those procedures necessitatingsuch positioning for an extended duration of time. Adjustment of theangles of the lumens with respect to one another is facilitated byovercoming the internal biasing force of the seal anchor member 100 byapplying a radial force to the surgical instrumentation placed withinthe lumens 108 a-c.

As previously discussed, FIG. 2A illustrates a seal anchor 90 includinglumens 98 that are parallel to one another. Inserted within lumens 98are surgical instruments 21 and camera 20. As seen in FIG. 2A, theparallel configuration of the lumens 98 hinder camera 20 in obtaining aclear view of the surgical site. It will be appreciated that thenon-parallel, intersecting configuration of the lumens 108 a-c of sealanchor 100 facilitate obtaining a lesser obstructed field of view thanwould be obtainable using seal anchor 90. In particular, as shown inFIG. 2B, axes “X” and “Z” define an angle “θ” therebetween. The greaterthe value of angle “θ”, the lesser the probability of surgicalinstruments 21 obstructing the view of camera 20. Moreover, the greaterthe angle “θ”, the lesser the probability of interference betweeninstruments 21 during the procedure. In addition, the greater the angle“θ”, the greater the number of internal structures included within thesurgical field and within reach of instruments 21.

Proximal end 102 of seal anchor member defines a first diameter D₁ anddistal end 104 defines a second diameter D₂. In one embodiment of sealanchor member 100, the respective first and second diameters D₁, D₂ ofthe proximal and distal ends 102, 104 are substantially equivalent, asseen in FIG. 1, although an embodiment of seal anchor member 100 inwhich diameters D₁, D₂ are different is also within the scope of thepresent disclosure. As depicted in FIG. 1, proximal and distal ends 102,104 define substantially planar surfaces. However, embodiments are alsocontemplated herein in which either or both of proximal and distal ends102, 104, respectively, define surfaces that are substantially arcuateto assist in the insertion of seal anchor member 100 within a tissuetract 12 defined by tissue surfaces 14 and formed in tissue “T”, e.g.,an incision, as discussed in further detail below.

Intermediate portion 106 defines a radial dimension “R” and extendslongitudinally between proximal and distal ends 102, 104, respectively,to define an axial dimension or length “L”. The radial dimension “R” ofintermediate portion 106 varies along the axial dimension, or length,“L” thereof. Accordingly, seal anchor member 100 defines across-sectional dimension that varies along its length “L”, whichfacilitates the anchoring of seal anchor member 100 within tissue “T”,as discussed in further detail below. However, an embodiment of sealanchor member 100 in which the radial dimension “R” remainssubstantially uniform along the axial dimension “L” thereof is alsowithin the scope of the present disclosure.

The radial dimension “R” of intermediate portion 106 is appreciably lessthan the respective diameters D₁, D₂ of proximal and distal ends 102,104 such that seal anchor member 100 defines an “hour-glass” shape orconfiguration to assist in anchoring seal anchor member 100 withintissue “T”, as discussed in further detail below. However, in analternate embodiment, the radial dimension “R” of intermediate portion106 may be substantially equivalent to the respective diameters D₁, D₂of proximal and distal ends 102, 104. In cross section, intermediateportion 106 may exhibit any suitable configuration, e.g., substantiallycircular, oval or oblong.

The seal anchor 100 may be adapted to transition from an expandedcondition to a compressed condition so as to facilitate the insertionand securement thereof within tissue tract 12 in tissue “T”. In theexpanded condition, seal anchor 100 is at rest and the respective radialdimensions D₁, D₂ of the proximal and distal ends 102, 104 of sealanchor 100, as well as the radial dimension R of the intermediateportion 106 are such that the seal anchor 100 cannot be inserted withintissue tract 12. However, the seal anchor 100 may transition to acompressed condition such that proximal and distal ends 102, 104, aswell as intermediate portion 106 are dimensioned for insertion intotissue tract 12.

To facilitate the transition between an expanded and a compressedcondition, the seal anchor 100 may be formed from a compressiblematerial having an internal biasing force such that the seal anchor 100will transition back to an expanded condition upon insertion of the sealanchor 100 within tissue tract 12, thereby ensuring a seal between theseal anchor 100 and the tissue tract 12. Seal anchor 100 may be formedfrom a shape memory material, a foam material, or a gel material, or thelike, but may also be formed from other materials. In an embodiment, theseal anchor 100 may be formed from a material selected from the groupconsisting of polyisoprene, urethane, and silicone.

Positioning members 114, 115 of the trailing and leading ends 102, 104,respectively, may engage the walls defining the body cavity of thetissue tract 12 to facilitate securement of seal anchor member 100within the body tissue. For example, positioning member 114 at leadingend 104 may engage the internal peritoneal wall and positioning member114 adjacent trailing end 102 may engage the outer epidermal tissueadjacent the incision 12 within tissue “T”. In another embodiment ofseal anchor member 100, one or more additional positioning members 114may be associated with intermediate portion 106.

The use and function of seal anchor member 100 will be discussed duringthe course of a typical minimally invasive procedure. Initially, theperitoneal cavity (not shown) is insufflated with a suitablebiocompatible gas such as, e.g., CO₂ gas, such that the cavity wall israised and lifted away from the internal organs and tissue housedtherein, providing greater access thereto. The insufflation may beperformed with an insufflation needle or similar device, as isconventional in the art. Either prior or subsequent to insufflation, atissue tract 12 is created in tissue “T”, the dimensions of which may bevaried dependent upon the nature of the procedure.

Different embodiments of seal anchors will be described with referenceto FIGS. 2 and 3. Seal anchors 200, 300 are substantially similar toseal anchor 100, except in the configuration of lumens and furtherinclude structures to stabilize instrumentation inserted within thelumens. Both seal anchor 200 and seal anchor 300, shown in FIGS. 2 and3, include lumens defining intersecting axes. Seal anchor 200 includes atrailing end 202 and a distal end 204. A plurality of lumens 208 isdisposed between the trailing and leading ends 202, 204. Lumens 208define openings in the trailing end 202 that are radially positionedalong the trailing end 202. A cut-out or groove 201 in the leading endextending outward from at least one lumen 208 facilitates stabilizationof instrumentation inserted within the lumen 208.

In an alternative embodiment, a seal anchor 300 including plurality oflumens disposed between leading and trailing ends 302, 304 is shown inFIG. 4. A cut-out or groove 301 in an arcuate or half-cylindricalconfiguration is disposed in the trailing end. At least one lumen 308 isdisposed within the groove 301. Groove 301 is adapted to facilitatestabilization of instrumentation inserted within the at least one of thelumens 308 that is disposed within the area defined by the groove 301.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, theabove description, disclosure, and figures should not be construed aslimiting, but merely as exemplifications of particular embodiments. Itis to be understood, therefore, that the disclosure is not limited tothose precise embodiments, and that various other changes andmodifications may be effected therein by one skilled in the art withoutdeparting from the scope or spirit of the disclosure.

What is claimed is:
 1. A surgical device comprising: a compressiblehousing defining a longitudinal axis, the compressible housing havingarcuate leading and trailing ends; the compressible housing defining aplurality of lumens extending between the leading and trailing ends,each lumen defining an axis, wherein at least a portion of each lumen isadapted to expand to accommodate an instrument in a substantially sealedmanner, and wherein, in an at-rest condition, the axis of a first andthe axis of a second lumen are nonparallel with respect to each otherand with respect to the longitudinal axis of the compressible housingand a third lumen is parallel to the longitudinal axis of thecompressible housing; the compressible housing comprising a leadingstructure defined in at least one of the leading and trailing ends ofthe compressible housing, the leading structure extending linearlyoutward from at least one of proximal and distal ends of two of theplurality of lumens, the leading structure configured to lead aninstrument into one of the two of the plurality of lumens, wherein theleading structure extends outward from the two of the plurality oflumens.
 2. The surgical device of claim 1, wherein the compressiblehousing comprises an intermediate portion having a proximal section thattapers inwardly in a distal direction and a distal section that tapersoutwardly in the distal direction.
 3. The surgical device of claim 1,wherein the leading structure is at least one of a groove and a cut-out.4. The surgical device of claim 1, wherein the compressible housing isformed from at least one of a foam and a gel.
 5. The surgical device ofclaim 4, wherein the compressible housing is formed from polyisoprene,urethane or silicone.
 6. The surgical device of claim 1, wherein thecompressible housing is configured to help maintain insufflationpressure in a body cavity during a minimally invasive laparoscopicsurgical procedure.
 7. The surgical device of claim 1, furthercomprising an insufflation tube.